Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults (FLU-A)
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ClinicalTrials.gov Identifier: NCT00819013 |
Recruitment Status
:
Completed
First Posted
: January 8, 2009
Results First Posted
: January 16, 2012
Last Update Posted
: January 19, 2012
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Tracking Information | ||||
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First Submitted Date ICMJE | October 10, 2008 | |||
First Posted Date ICMJE | January 8, 2009 | |||
Results First Submitted Date | November 1, 2011 | |||
Results First Posted Date | January 16, 2012 | |||
Last Update Posted Date | January 19, 2012 | |||
Study Start Date ICMJE | July 2007 | |||
Actual Primary Completion Date | January 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Safety and reactogenicity of ACAM-FLU-A with and without adjuvant compared to placebo control in healthy adult subjects. [ Time Frame: one and one half years ] | |||
Change History | Complete list of historical versions of study NCT00819013 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Immunogenicity profile following two doses of ACAM-FLU-A with and without adjuvant compared to placebo control. [ Time Frame: one and one half years ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults | |||
Official Title ICMJE | A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Safety, Reactogenicity, and Immunogenicity of Recombinant M2e Influenza-A Vaccine Candidate ACAM FLU-A) in Healthy Adults | |||
Brief Summary | This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered. Subjects will be randomized according to a randomization scheme. |
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Detailed Description | All subjects will be followed up for 60 days post-randomization and through the influenza season. Following the influenza season, a subset of the subjects will receive a booster vaccine at the 12 month time point. The subjects will further be assessed at 2 days, 7 days, 15 days, 30 days and 6 months following the booster vaccination. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Influenza | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Ibañez LI, Roose K, De Filette M, Schotsaert M, De Sloovere J, Roels S, Pollard C, Schepens B, Grooten J, Fiers W, Saelens X. M2e-displaying virus-like particles with associated RNA promote T helper 1 type adaptive immunity against influenza A. PLoS One. 2013;8(3):e59081. doi: 10.1371/journal.pone.0059081. Epub 2013 Mar 18. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
87 | |||
Original Actual Enrollment ICMJE |
80 | |||
Actual Study Completion Date | February 2009 | |||
Actual Primary Completion Date | January 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 40 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00819013 | |||
Other Study ID Numbers ICMJE | H-261-001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Sanofi | |||
Study Sponsor ICMJE | Sanofi | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Sanofi | |||
Verification Date | January 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |